EyeBio Announces First Patients Dosed in Phase 1b/2 Trial of Restoret in Wet AMD and DME
Eyebiotech announced the dosing of the first participants in its phase 1b/2 AMARONE (Anti-permeability Mechanism and Age-Related Ocular Neovascularization Evaluation) clinical trial in patients with diabetic macular edema (DME) and wet age-related macular degeneration (AMD). The AMARONE trial will evaluate the safety and preliminary efficacy of intravitreal (IVT) Restoret (EYE103) and is the first clinical trial from EyeBio’s pipeline of multi-specific antibodies.
“Restoret has the potential to address a major unmet need in these diseases, namely excess fluid in the retina,” Tony Adamis, MD, Chief Scientific Officer of EyeBio, said in a company news release. “Anti-VEGF registrational trials and real-world data both show that excess fluid leads to poorer vision, and the longer that fluid resides in the retina, the less opportunity there is to recover vision. Improved drying of the retina is the clearest opportunity for improvement in patients’ outcomes. Restoret addresses a new biology, which is critical if we want to deliver results beyond those seen with anti-VEGF alone.”
Restoret is an investigational, intravitreally delivered, tri-specific antibody that acts as an agonist of the Wnt signaling pathway. It is designed to resolve residual fluid in the retina and to improve visual acuity in individuals with wet AMD and DME, as well as other retinal diseases of permeability.
“Initiation of the AMARONE trial marks an important milestone in our mission to address the urgent unmet need for individuals living with neovascular age-related macular degeneration and diabetic macular edema,” said Jonathan Prenner, MD, Chief Medical Officer of EyeBio. “More than 60 percent of patients have suboptimal outcomes and more than 30 percent have active disease despite treatment with anti-VEGF agents. Restoret may present an opportunity to break through the efficacy ceiling we have reached with anti-VEGF standard of care.”
The first participants dosed in the AMARONE trial were treated by J. Edward Ysasaga, MD, of Southwest Retina Specialists, and Mark Barakat, MD, of Retinal Consultants of Arizona.
About the AMARONE Clinical Trial
The phase 1b/2 AMARONE (Anti-permeability Mechanism and Age-Related Ocular Neovascularization Evaluation) clinical trial is a multicenter two-part trial consisting of an open-label multiple ascending dose (MAD) safety study, and a dose-finding single-masked comparative safety and preliminary efficacy study of intravitreal (IVT) Restoret (EYE103) in participants with diabetic macular edema (DME) and wet age-related macular degeneration (AMD). The trial plans to enroll up to 92 participants, who will receive 12-week regimens of Restoret. The primary endpoints of the AMARONE trial are safety and mean change in best-corrected visual acuity (BCVA) from baseline to Week 12 in the study eye of the participants, using the standardized ETDRS (Early Treatment of Diabetic Retinopathy Study).
About Restoret, a Wnt agonist tetravalent tri-specific antibody
Restoret is a tri-specific Wnt agonist antibody, built based on AntlerA’s ANT-Pharm technology. It is designed to address urgent unmet medical need in patients with back-of-the-eye diseases. Restoret aims to eliminate leakage in vascular diseases by agonizing the Wnt pathway to both restore and maintain the blood-retinal barrier. The result of a breakthrough in molecular design, Restoret will enable the clinical translation of the extensively studied Wnt pathway for the first time in the eye. Published research has shown that Wnt signaling in the retina plays a central role in the maintenance of vascular integrity, and defects in Wnt signaling cause retinal vascular leakage. A mimetic of norrin, which is the natural Wnt ligand in the eye, Restoret has demonstrated efficacy in preclinical ophthalmic models, including validation in genetic models.